Minerva Neurosciences Inc Q2 2021 Earnings Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Myles Robert Minter - William Blair & Company L.L.C., Research Division - Analyst : I just wanted to go back to the mITT analysis of the Phase III trial. I know that was prespecified in the statistical analysis plan. I'm wondering whether you could tell me at what point of the statistical hierarchy that analysis on the primary endpoint in the mITT population actually sat. I'm aware you've disclosed nominal p-values here, and I understand it has to be nominal. But I'm trying to understand the potential degree of multiplicity to apply to that. So I just want to know where it sat in that original samp. If you could provide any color on that, that would be great.

Question: Myles Robert Minter - William Blair & Company L.L.C., Research Division - Analyst : Okay. Fair enough. And then on the bioequivalence study, obviously, the protocol is being run past the agency and that they are aligned with it. I'm curious as to whether you've had conversations with them about their comfort level with this commercial formulation from Catalent that you will likely not have clinical and safety data outside of the healthy volunteers here prior to submitting for NDA. Like are they happy with the fact that the Phase IIb and the Phase III formulations, you have clinical data around that, but maybe you won't have that for the commercial formulation. There's no chance that make you like try and run an additional study or something, yes?

Question: Myles Robert Minter - William Blair & Company L.L.C., Research Division - Analyst : Congrats on the open-label data as well and continue the progress. I'll jump back in the queue.